- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02290392
Minority Health Genomics and Translational Research Bio-Repository Database (MH-GRID)-2.0
The Minority Health Genomics and Translational Research BIo-Repository Database (MH-GRID)-2.0
Background:
- High blood pressure is a common problem. It can cause heart attacks, strokes, and kidney failure. It affects African Americans more than other racial groups. Data were collected from over a thousand African Americans across the country. The data were put into a database (MH-GRID). The data were about genes, diet, sleep, body mass index. They also cover stress and access to healthy foods and parks. Researchers at NIH will study these data in new ways. They want to learn more about the connection between African Americans and high blood pressure.
Objective:
- To study MH-GRID data to find the causes of severe high blood pressure and other cardio-metabolic problems in people of African ancestry.
Eligibility:
- African Americans age 30 55 with severe high blood pressure were used in the MH-GRID study. No new participants will be enrolled in this study.
Design:
- Researchers will examine data from the MH-GRID study.
Study Overview
Status
Conditions
Detailed Description
The etiology of racial/ethnic differences in health involves dynamic interactions between
genetic, behavioral and social-environmental determinants. Despite this, the field lacks robust
datasets that integrate these determinants with clinical assessments in minority patient cohorts. The Minority Health Genomics and Translational Research Bio-repository Database (MHGRID) Network infrastructure facilitated the collection of biospecimens and related multidimensional data elements within a consortium of minority-serving clinics. This initiative expands the diversity of ancestral groups in national genomic medicine datasets and promises to accelerate the translation of personalized medicine into minority communities. The MH-GRID project was initiated by Dr. Gibbons (founding PI) prior to becoming an NIH investigator. The MH-GRID project has completed its participant recruitment activities, closed out its NIH funding and now represents an existing dataset and biorepository that is being transferred to NHGRI for ongoing secondary analyses. A variety of investigations will be conducted on this existing dataset. The primary outcome variables include severe hypertension and hypertension induced kidney damage. Secondary outcome variables include obesity, coronary heart disease and metabolic disease syndrome. Intervening variables include genetics, behavioral (i.e. sleep quality, health literacy, smoking, diet, body mass index), ancestry, social (i.e. socioeconomic status, racial discrimination, stress, social depreivation), biological (i.e. insulin resistance, cholesterol, inflammatory markers), and environmental (i.e. neighborhood, access to healthy foods, parks).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Human Genome Research Institute (NHGRI)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Description
- INCLUSION CRITERIA:
- The MH-GRID Project s inclusion criteria included AA age 30-55 years
- Severe controlled HTN or severe resistant HTN.
EXCLUSION CRITERIA:
- Exclusion criteria involved patients with secondary forms of HTN, primary forms of kidney disease or major co-morbidities (e.g. diabetes, heart failure, end-stage renal failure, HIV, and liver disease).
- Children <18 were not enrolled in the protocol.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
African Americans age 30-55 years with severe controlled HTN or severe resistant HTN.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To complete the original MH-GRID primary outcome analyses by defining the genetic, behavioral , and social-environmental determinants of severe hypertension and other cardio-metabolic disorders in individuals of African ancestry.
Time Frame: one time analysis
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To complete the original MH-GRID primary outcome analyses by defining the genetic, behavioral , and social-environmental determinants of severe hypertension and other cardio-metabolic disorders in individuals of African ancestry.
|
one time analysis
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The secondary outcome variables include obesity, coronary heart disease and metabolic disease syndrome. Intervening variables include genetics, behavioral, ancestry, social, biological, and environmental.
Time Frame: one time analysis
|
The secondary outcome variables include obesity, coronary heart disease and metabolic disease syndrome.
Intervening variables include genetics, behavioral, ancestry, social, biological, and environmental.
|
one time analysis
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Amadou Gaye, M.D., National Human Genome Research Institute (NHGRI)
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999915011
- 15-HG-N011
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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